Data Foundry

Medical device recalls 2022

ProPlan CMF Anatomical Model — Class II medical device recall Z-1569-2022

Completed recall by Materialise USA LLC, reported 2022-08-31, distributed nationwide. MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

Recall numberZ-1569-2022
Product typeMedical device
ClassificationClass II
StatusCompleted
Voluntary or mandatedVoluntary
Recalling firmMaterialise USA LLC, Plymouth, MI, United States
Recall initiated2022-07-13
Classified2022-08-24
Reported by FDA2022-08-31
DistributedNationwide (US)
Quantity1 units
Reason classeslabeling
UPC / GTIN / UDI-DI05420060352089
Lot numbersMU22-INQ-DUQ

Product

ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208

Reason for recall

MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was shipped with the Anatomical Model of case MU22-NOF-SAK

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1569-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.